BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS LIFESCIENCES ESHEATH INTRODUCER SET

    MDR report key: 12008113 · Received June 15, 2021

    Report

    Report Number
    MW5101903
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 11, 2021
    Manufacturer
    EDWARDS LIFESCIENCES LLC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE EDWARDS TAVR SHEATH WAS REMOVED FROM THE PATIENTS GROIN IT WAS NOTED THAT A PORTION OF THE TIP OF THE SHEATH WAS MISSING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894051 EDWARDS LIFESCIENCES ESHEATH INTRODUCER SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES LLC. 63505975

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR